Commercial Insight: Rheumatoid arthritis - Anti-TNFs defend first-line biologic position despite competition
| Publication Date | December 2008 |
|---|---|
| Publisher | Datamonitor |
| Product Type | Report |
| Pages | 272 |
| ISBN Number | not applicable |
| Product Code | DAT14045 |
Buy this product or for assistance call +44 20 7060 7474
Summary
Introduction
Datamonitor forecasts that total sales for the seven major rheumatoid arthritis markets will grow from $7 billion in 2007 to over $12 billion in 2017. The sustained uptake of anti-TNFs combined with the launch of several new biologic products will drive growth in the short-and mid-term. However, biosimilar entry will cause a small contraction in market value at the end of the forecast period.
Scope
- In-depth analysis of the current and future rheumatoid arthritis market across the US, 5EU and Japanese markets, and a 'rest of world' snapshot.
- Rheumatoid arthritis sales forecasts for over 20 key brands to 2017, and total brand figure to benchmark indication-specific sales
- Provides detailed brand analysis, including discussion of all anti-TNFs and impact of alternative biologic products like Actemra
- Assess the strategies of several key developers in the rheumatoid arthritis market
Highlights
Simponi (golimumab) exemplifies a brand adopting both follow-on and dual formulation strategies, but positioning with Remicade will be challenging. Careful brand management, sales and marketing efforts and a well executed switching strategy will see Simponi achieve blockbuster status in the seven major markets.
The TNF-failure pool will increase considerably as patients cycle through a maximum of 2-3 TNF therapies. Currently, Orencia and Rituxan/MabThera compete in this sub-population, which will become increasingly crowded. With its well-perceived safety profile and Actemra's US approval delay, Orencia will cement its first-line position in TNF-failures.
Although some novel biologic products, have amassed convincing efficacy data against anti-TNFs, their use will be limited to the anti-TNF failure patient population, at least in the mid-term. To progress up the treatment algorithm, new agents need to demonstrate superiority to anti-TNFs and show cost-effectiveness.
Reasons to Purchase
- Quantify the current size of rheumatoid arthritis sales in the seven major markets and understand trends in the Rest of World
- Assess the commercial opportunities for non-anti-TNF biologic products including Orencia, Rituxan/MabThera, Actemra, ocrelizumab and ofatumumab
- Detailed case studies analysing Simponi's product positioning and epidemiology-based assessment of biologic therapies by line and type of therapy
Content
- ABOUT DATAMONITOR HEALTHCARE
- About the Immunology & Inflammation pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- CHAPTER 2 MARKET DEFINITION
- Market definition for this report
- Biologic DMARDs
- TNF inhibitors
- Interleukins
- Selective T cell co-stimulation modulator
- B cell targets
- Traditional DMARDs (non-biologic DMARDs)
- ICD-10 codes used to define the rheumatoid arthritis market
- Assumptions and caveats for diagnosis value estimates
- Diagnosis value based on retail data only
- CHAPTER 3 MARKET OVERVIEW
- Seven major markets
- Current and future market assessment
- TNF inhibitors drove growth in the seven major rheumatoid arthritis markets between 2004 and 2007
- Launch of two new biologic classes contributed to growth in the rheumatoid arthritis market between 2004 and 2007
- US is the largest rheumatoid arthritis market, but 5EU and Japan experienced higher sales growth between 2004 and 2007
- Rheumatoid arthritis market volume is increasing, but due to the uptake of biologics, sales growth is outstripping it
- The seven rheumatoid arthritis markets will grow from $7,245m in 2007 to $12,568m in 2017
- Opportunities and threats
- Opportunities
- Threats
- US
- Current and future market assessment
- US experienced the lowest sales growth between 2004 and 2007
- US will continue to be the largest of the seven rheumatoid arthritis markets
- Opportunities and threats
- Opportunities
- Threats
- Japan
- Current and future market assessment
- Japan was the fastest growing market from 2004 to 2007
- 2017 rheumatoid arthritis sales in Japan will be almost double sales in 2007
- Opportunities and threats
- Opportunities
- Threats
- Five major European markets (5EU)
- Current and future market assessment
- Opportunities and threats
- Opportunities
- Threats
- France
- Current and future market assessment
- Germany
- Current and future market assessment
- Italy
- Current and future market assessment
- Spain
- Current and future market assessment
- UK
- Current and future market assessment
- Rest of World snapshot
- Current market assessment
- Rest of World forms only 15% of global rheumatoid arthritis market sales
- Humira's sales drove growth in US, 5EU and the rest of world from 2004 to 2007
- Asia-Pacific experienced the fastest growth in the Rest of World between 2004 and 2007
- Canada is the largest of the Rest of World markets
- CHAPTER 4 BRAND DYNAMICS
- Overview of competitive landscape
- Patient acquisition process
- Introduction
- Patient care path
- Points of influence in the patient care path
- Trigger Point 1: Disease duration and activity influence use of biologics
- Trigger Point 2: Movement from anti-TNFs to biologics with alternative mechanisms of action
- Drivers of brand choice
- Disease modification and side-effects are the most important factors to prescribing physicians
- Factors driving brand choice in the anti-TNF class
- Patient preference can influence anti-TNF choice
- Patients wish to participate in treatment decisions regarding anti-TNFs
- Factors driving brand choice in the cytokine drug class
- Similar choice between anti-TNFs and cytokines
- US formulary status for leading brands
- Enbrel has the most favorable formulary status of the biologic DMARDs
- Trends in marketing strategies
- Datamonitor's dosing assumptions for brand forecasts
- TNF inhibitors
- Efficacy of TNF inhibitors
- Safety of TNF inhibitors
- TNF inhibitors - sales forecast to 2017
- Enbrel (etanercept; Amgen, Wyeth, Takeda)
- Product profile
- Product positioning
- Marketing mix
- SWOT analysis
- Brand forecast to 2017
- Remicade (infliximab; Centocor/Johnson & Johnson, Schering-Plough and Mitsubishi Tanabe)
- Product profile
- Product positioning
- Marketing mix
- SWOT analysis
- Brand forecast to 2017
- Humira (adalimumab; Abbott, Eisai)
- Product profile
- Product positioning
- Marketing mix
- Brand forecast to 2017
- Simponi (golimumab; Centocor/Johnson & Johnson, Schering-Plough, Mitsubishi Tanabe, Janssen Pharmaceutical)
- Target product profile
- Development overview
- Product positioning
- SWOT analysis
- Drug forecast to 2017
- Cimzia (certolizumab; UCB, Otsuka)
- Target product profile
- Development overview
- Product positioning
- Marketing mix
- SWOT analysis
- Drug forecast to 2017
- Other cytokine targets (non-TNF biologics)
- Other cytokine targets - sales forecast to 2017
- Actemra (tocilizumab; Chugai, Roche)
- Product profile
- Development overview
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Orencia (abatacept; Bristol-Myers Squibb)
- Product profile
- Product positioning
- Marketing mix
- SWOT analysis
- Brand forecast to 2017
- Rituxan/MabThera (rituximab; Genentech, Biogen Idec, Roche and Chugai)
- Product profile
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Ocrelizumab (Genentech, Biogen Idec, Roche and Chugai)
- Target product profile
- Development overview
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Ofatumumab (Genmab, GlaxoSmithKline)
- Target product profile
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Other promising late-stage pipeline agents
- JAK inhibitors
- CHAPTER 5 KEY DEVELOPERS
- Strategic overview
- Trends in corporate strategy
- Several companies will enter the market with follow-on products
- Companies are going for dual subcutaneous and intravenous delivery formulations
- Amgen
- Corporate strategy
- Rheumatoid arthritis portfolio assessment
- Roche
- Corporate strategy
- Rheumatoid arthritis portfolio assessment
- Bristol-Myers Squibb
- Corporate strategy
- Rheumatoid arthritis portfolio assessment
- CHAPTER 6 CASE STUDIES
- Case study 1 - Patient-based rheumatoid arthritis market forecasts
- Comparison between patient-based forecast and IMS forecast
- Methodology
- Sensitivity analysis
- Case study 2 - Portfolio management: Simponi's (golimumab) positioning strategy
- Scenario A - Immediate switch to subcutaneous formulation
- Scenario B - Delayed switch to intravenous formulation
- Conclusion - Scenario B benefits Simponi and anti-TNF franchise
- Simponi (golimumab, CNTO-148) pricing scenarios
- BIBLIOGRAPHY
- Journal papers
- Websites
- Datamonitor reports
- Publications
- APPENDIX A - MARKET ASSUMPTIONS
- New product launches
- Patent expiries
- US
- Arava (leflunomide) used as a case study for brand erosion after small molecule patent expiry in the US
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Rest of World
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- APPENDIX B
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Immunology & Inflammation analysis team
- Disclaimer
- Table 1: Datamonitor's definition of rheumatoid arthritis
- Table 2: Rheumatologist breakdown by region for IMS Prescribing Insight data, 2007
- Table 3: Rheumatoid-arthritis specific sales ($m) split by drug class in the seven major markets, 2004-07
- Table 4: Rheumatoid arthritis-specific volume sales (million standard units) split by drug class in the seven major markets, 2004-07
- Table 5: Sales forecasts in rheumatoid arthritis in the seven major markets ($m), 2007-2017
- Table 6: Patent expiry dates and level of biosimilar risk for the biologic brands for rheumatoid arthritis
- Table 7: Cost ($) per year per patient for common biologic agents prescribed for rheumatoid arthritis in the US, 2007
- Table 8: Summary of opportunities and threats in the seven major rheumatoid arthritis markets, 2008
- Table 9: Sales and growth of rheumatoid arthritis drug classes in the US, 2007
- Table 10: Sales forecasts in rheumatoid arthritis in US ($m), 2007-2017
- Table 11: Summary of opportunities and threats in the rheumatoid arthritis market in the US, 2007
- Table 12: Japan sales and growth of anti-TNF and traditional DMARD drug classes, 2007
- Table 13: Sales forecasts in rheumatoid arthritis in Japan ($m), 2007-2017
- Table 14: Summary of opportunities and threats in the rheumatoid arthritis market in Japan, 2007
- Table 15: Sales of the Top-10 rheumatoid arthritis drugs in the five major EU markets ($m), 2007
- Table 16: Sales forecasts for rheumatoid arthritis in the five major European markets ($m), 2007-2017
- Table 17: Summary of opportunities and threats for rheumatoid arthritis in the five major European markets, 2008
- Table 18: Sales forecasts in rheumatoid arthritis in France ($m), 2007-2017
- Table 19: Sales forecasts in rheumatoid arthritis in Germany ($m), 2007-2017
- Table 20: Sales forecasts in rheumatoid arthritis in Italy ($m), 2007-2017
- Table 21: Sales forecasts in rheumatoid arthritis in Spain ($m), 2007-2017
- Table 22: Sales forecasts in rheumatoid arthritis in the UK ($m), 2007-2017
- Table 23: Comparison of leading branded drug sales ($m) for rheumatoid arthritis in the seven major markets and the Rest of World (ROW), 2007
- Table 24: Leading branded drug sales ($m) for rheumatoid arthritis, 2007-2017
- Table 25: Key products in late-stage R&D pipeline for rheumatoid arthritis, 2008
- Table 26: Mean scores for considerations in choosing biologic response modifier therapy for rheumatoid arthritis, 2008
- Table 27: Summary of patient preferences regarding anti-TNF therapy, showing first choices only
- Table 28: Factors influencing prescribing decision for anti-TNFs and cytokine biologics in rheumatoid arthritis in the seven major markets, 2008
- Table 29: Formulary status in the US for leading brands in rheumatoid arthritis, 2008
- Table 30: Datamonitor's standard unit definition and dosing assumptions for marketed and pipeline products in rheumatoid arthritis market, 2008
- Table 31: Efficacy of the anti-TNFs: American College of Rheumatology 20, 50 and
- Table 32: Safety of TNF inhibitors, 2008
- Table 33: Enbrel - Drug profile, 2008
- Table 34: Ongoing and recently completed clinical trials of Enbrel (etanercept) in juvenile idiopathic rheumatoid arthritis, 2008
- Table 35: Impacting factors on the revenues of Enbrel, 2007-2017
- Table 36: Remicade - Drug profile, 2008
- Table 37: Ongoing post-marketing studies for Remicade in rheumatoid arthritis, 2008
- Table 38: Impacting factors on the revenues of Remicade, 2007-2017
- Table 39: Humira - Drug profile, 2008
- Table 40: Impacting factors on the revenues of Humira, 2007-2017
- Table 41: Simponi - Target product profile, 2008
- Table 42: Clinical trial summary for subcutaneous formulation of Simponi (golimumab)
- Table 43: Clinical trial summary for intravenous formulation of Simponi (golimumab), 2008
- Table 44: Simponi (golimumab) efficacy summary: Clinical trial data from GO-FORWARD, GO-AFTER and GO-BEFORE, 2008
- Table 45: Comparison of the route of administration and dosing frequency of the anti-TNFs in rheumatoid arthritis
- Table 46: Impacting factors on the revenues of Simponi (golimumab), 2007-2017
- Table 47: Cimzia- Target product profile, 2008
- Table 48: Cimzia (certolizumab): Pivotal Phase III clinical trials
- Table 49: Cimzia (certolizumab): Ongoing clinical trials, 2008
- Table 50: Results of Cimzia's RAPID-1 and RAPID-2 clinical trials
- Table 51: Impacting factors on the revenues of Cimzia, 2007-2017
- Table 52: Actemra - Drug profile, 2008
- Table 53: Actemra (tocilizumab): Pivotal Phase III trials
- Table 54: Actemra (tocilizumab): summary of results from pivotal Phase III trials OPTION, TOWARD, RADIATE and AMBITION
- Table 55: LITHE study results: Inhibition of radiographic progression at Week
- Table 56: Actemra (tocilizumab): summary of results from SAMURAI and SATORI trials
- Table 57: Impacting factors on the revenues of Actemra, 2007-2017
- Table 58: Orencia - Drug profile, 2008
- Table 59: Completed Phase III clinical trials for Orencia (abatacept)
- Table 60: Ongoing clinical trials for Orencia (abatacept) in rheumatoid arthritis, 2008
- Table 61: The efficacy of abatacept in methotrexate-nave patients with early erosive rheumatoid arthritis and poor prognostic factors, 2008
- Table 62: Phase IIIb studies for subcutaneous formulation of Orencia (abatacept), 2008
- Table 63: Impacting factors on the revenues of Orencia, 2007-2017
- Table 64: Rituxan/MabThera - Drug profile, 2008
- Table 65: Comparison of ACR efficacy scores in the TNF-failure patient population: Rituxan/MabThera versus Orencia
- Table 66: Impacting factors on the revenues of Rituxan/MabThera, 2007-2017
- Table 67: Ocrelizumab - Drug profile, 2008
- Table 68: Ocrelizumab ACR efficacy data from Phase II ACTION trial, 2007
- Table 69: Ocrelizumab Phase III clinical trial details, 2008
- Table 70: Impacting factors on the revenues of ocrelizumab, 2007-2017
- Table 71: Ofatumumab - Drug profile, 2008
- Table 72: Comparison of ofatumumab versus rituximab, 2008
- Table 73: Ofatumumab's ACR and EULAR efficacy scores in DMARD-failure patients, 2007
- Table 74: Efficacy of ofatumumab in DMARD-failure patients: 48 Week follow-up, 2008
- Table 75: Ofatumumab: Ongoing Phase III and Phase II clinical trials, 2008
- Table 76: Impacting factors on the revenues of ofatumumab, 2007-2017
- Table 77: JAK inhibitors in development for rheumatoid arthritis, 2008
- Table 78: CP-690,550: Phase IIb efficacy data, 2008
- Table 79: Leading companies in the seven major rheumatoid arthritis markets, 2007-17
- Table 80: Assessment of Amgen's rheumatoid arthritis portfolio, 2008
- Table 81: Assessment of Roche's rheumatoid arthritis portfolio, 2008
- Table 82: Assessment of Bristol-Myers Squibb's rheumatoid arthritis portfolio, 2008
- Table 83: Scenario A: Simponi's US events and market share assumptions from launch in 2009
- Table 84: Scenario B: Simponi's events and market share assumptions from launch
- Table 85: Centocor/Johnson & Johnson's anti-TNF franchise sales in rheumatoid arthritis in the US, 2007-17
- Table 86: Datamonitor's pricing scenarios for Simponi in the US, 2008
- Table 87: Datamonitor's launch dates for rheumatoid arthritis products in the 5EU and US, 2007-2017
- Table 88: Arava's brand erosion from time of first generic entrant, Q2 2005 to Q2 2007
- List of Figures
- Figure 1: Rheumatoid arthritis sales ($m) by drug class in the seven major markets, 2004-07
- Figure 2: Key events impacting the rheumatoid arthritis market, 2005-08
- Figure 3: Sales performance of the US, five major EU and Japan rheumatoid arthritis markets, 2006-07
- Figure 4: Rheumatoid arthritis-specific sales ($m) by country, 2004-2017
- Figure 5: Rheumatoid arthritis sales in the seven major markets, split by country, 2007-17
- Figure 6: Number of rheumatoid arthritis patients receiving anti-TNF and non-TNF biologics in the seven major markets, 2007-17
- Figure 7: Rheumatoid arthritis sales ($m) by drug class in US, 2004-07
- Figure 8: US rheumatoid arthritis-specific sales by class, 2004-17
- Figure 9: Rheumatoid arthritis-specific sales split by class in Japan ($m), 2004-07
- Figure 10: Rheumatoid arthritis-specific of Remicade (infliximab) and Enbrel (etanercept), 2004-07
- Figure 11: Performance of the key rheumatoid arthritis therapies in Japan ($m), 2005-2006
- Figure 12: Japan rheumatoid arthritis-specific sales by class, 2004-17
- Figure 13: Price per standard unit ($/SU) for Remicade (infliximab) in Japan, Q1 2007-Q2 2008
- Figure 14: Rheumatoid arthritis-specific sales split by class in the 5EU ($m), 2004-07
- Figure 15: Five major EU rheumatoid arthritis-specific sales by class, 2004-17
- Figure 16: Five major EU rheumatoid arthritis-specific sales by class, 2004-17
- Figure 17: France rheumatoid arthritis-specific sales by class, 2004-17
- Figure 18: Germany rheumatoid arthritis-specific sales by class, 2004-17
- Figure 19: Italy rheumatoid arthritis-specific sales by class, 2004-17
- Figure 20: Spain rheumatoid arthritis-specific sales by class, 2004-17
- Figure 21: Rheumatoid arthritis-specific sales split by class in UK ($m), 2004-07
- Figure 22: Rest of World versus seven major market sales split in the rheumatoid arthritis market ($m), 2007
- Figure 23: Annual sales ($m) in the Rest of World rheumatoid arthritis markets, split by region, 2004-07
- Figure 24: Sales value of the largest 10 individual rheumatoid arthritis markets in the Rest of World, 2004-07
- Figure 25: Rheumatoid arthritis patient care path, 2008
- Figure 26: Drivers of brand choice for rheumatoid arthritis, 2008
- Figure 27: Percentage of responses to question about who should choose treatment for patients with rheumatoid arthritis
- Figure 28: Assessment of formulary status of leading biologic DMARDS in the US, 2008
- Figure 29: Rheumatoid arthritis sales ($m) for TNF inhibitors in the seven major markets, 2004-17
- Figure 30: Type of promotional activity for Enbrel as a percentage of total promotional spend in the US and five major EU markets, Q3 2005-Q2 2008
- Figure 31: Wyeth/Amgen's advertisement for Enbrel in juvenile idiopathic arthritis from the ACR Scientific Meeting, 2008
- Figure 32: Enbrel (etanercept): SWOT analysis, 2008
- Figure 33: Enbrel sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 34: Type of promotional activity for Remicade as a percentage of promotional spend in the US and five major EU markets, Q3 2005-Q2 2008
- Figure 35: Remicade (infliximab): SWOT analysis, 2008
- Figure 36: Remicade sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 37: Type of promotional activity for Humira as a percentage of total promotional spend in the US and five major EU markets, Q3 2005-Q2 2008
- Figure 38: Humira (adalimumab): SWOT analysis, 2008
- Figure 39: Humira (adalimumab) sales ($m) by country in the seven major markets, 2007-17
- Figure 40: Simponi (golimumab): SWOT analysis, 2008
- Figure 41: Simponi (golimumab) sales ($m) by country in the seven major markets, 2007-17
- Figure 42: Type of promotional activity for Cimzia as a percentage of total promotional spend in the US, Q2 2008
- Figure 43: Cimzia (certolizumab): SWOT analysis, 2008
- Figure 44: Cimzia sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 45: Rheumatoid arthritis sales ($m) for other cytokine targets in the seven major markets, 2074-17
- Figure 46: Actemra (tocilizumab): SWOT analysis, 2008
- Figure 47: Actemra sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 48: Promotional activity for Orencia by type as a percentage of promotional spend the US and EU (France, Germany, UK), Q3 2005-Q2 2008
- Figure 49: Orencia (abatacept): SWOT analysis, 2008
- Figure 50: Orencia sales ($m), split by formulation, in rheumatoid arthritis in the seven major markets, 2007-2017
- Figure 51: Orencia sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 52: Orencia, Rituxan/MabThera and Actemra sales ($m) in rheumatoid arthritis in the seven major markets, 2007-2017
- Figure 53: Rituxan/MabThera (rituximab): SWOT analysis, 2008
- Figure 54: Rituxan/MabThera sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 55: Ocrelizumab: SWOT analysis, 2008
- Figure 56: Ocrelizumab sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 57: Rituxan/MabThera (rituximab) and ocrelizumab sales ($m) in rheumatoid arthritis in the seven major markets, 2007-2017
- Figure 58: Ofatumumab: SWOT analysis, 2008
- Figure 59: Ofatumumab sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017
- Figure 60: Ofatumumab sales ($m), split by formulation, in rheumatoid arthritis in the seven major markets, 2007-2017
- Figure 61: Overview of key players with marketed and pipeline drugs in rheumatoid arthritis market, 2008
- Figure 62: Estimated number of patients treated with biologics split by line and type of therapy, 2006-17
- Figure 63: Estimated rheumatoid arthritis sales ($m) forecast for biologic brands in the seven major markets, 2006-17
- Figure 64: Estimated uptake of biologics in moderate and severe rheumatoid arthritis patients in the seven major markets, 2006-17
- Figure 65: Datamonitor's estimated percentage of patients receiving biologics, by type of therapy, at each line of therapy in 2007 and 2017
- Figure 66: Datamonitor's sensitivity analysis for biologic sales ($m) in rheumatoid arthritis in the seven major markets, 2017
- Figure 67: Simponi's rheumatoid arthritis sales in the US assuming an immediate switch from Remicade to subcutaneous Simponi formulation, 2007-17
- Figure 68: Simponi's rheumatoid arthritis sales in the US assuming a delayed switch from Remicade to intravenous Simponi formulation, 2007-17
- Figure 69: Simponi's rheumatoid arthritis sales under each pricing scenario in the US, 2007-17
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